NJK & Associates, Inc.

Helping you jump your highest regulatory hurdles

  • Quality Systems - Implementation

    Obtaining a Quality System is only the start.  The Quality System Regulation says that must "establish" your quality system. Establish is defined in 21 CFR 820.3(k) as follows:

    "Establish means define, document (in writing or electronically), and implement"

    We have helped clients large and small to establish quality systems that meet the needs of their organizations while complying with the letter and intent of the regulations. Our systems are compliant with the ISO Standards as well so you don't need to redo your system when seeking ISO 13485 certification.

    What types of medical device companies are using our systems?

    • Obital Implant
    • Intraocular Lens
    • Molecular Diagnostic
    • Genomics
    • Orthopedic Implants
    • Spinal Implants
    • Lateral Flow IVD
    • Patient monitoring
    • Cardiac monitoring
    • Flow cytometers
  • Quality Systems - Audit Remediation

    So you had an  FDA or Notified Body audit and they found deficiencies. How and when you respond can make a profound difference in how things get resolved.

    We have extensive experience in helping companies avoid or more quickly remediate Warning Letters and successfully wrote and implemented a CAP to help a company survive being placed on the Application Integrity List.

    We can help by teaching you what the Agency means in 483 and Warning Letter citations and how to best respond. We can also assist in implementing the fixes needed.

  • Quality Systems - Administration

    Your company adds value by developing and marketing your products. In many cases it is more cost effective to outsource the administration of your Quality System to specialists.

    We can handle most of your Quality System needs remotely or in person.

    We can provide secure hosting of your quality system documents and serve as  your virtual document control department.

    We also do complaint handling for a number of our clients, providing an on-line form to assist in transferring pertinent information to us for evaluating, documenting, and if needed submission of eMDR reports to FDA.

    If you desire an even more comprehensive solution check out the tabs below.

  • Regulatory Affairs - Advisory - US & ROW

    You've got a new product in development or want to make a change to an existing device and don't know what regulations, standards, and guidance documents apply.

    We are here to help with regulatory strategies based upon our vast experience with clients just like you. We can contrast various strategies help you decide on how to proceed, and can then work with your people to make it happen.

  • Regulatory Affairs - Pre-submission

    Bringing a medical device to market can take large amounts of time and money. When your device is novel or if clinical data is needed the time and expenses rise. What you least want is to have your submission rejected by FDA for inadequately addressing things that they could have told you early in the game.

    We have done many pre-submissions where we presented our regulatory and clinical plans to FDA, received their feedback, and negotiated to the most reasonable terms that could be obtained.

  • Regulatory Affairs - Premarket Submission

    When its time to write your 510(k) submission we can get it done in a timely manner and get it to the Agency looking like the well thought out work that it represents.

    Doing it yourself risks the Refuse to Accept policy as well as a series of Additional Information requests. While we can't promise that these won't occur, our experience in writing submissions provides you with better odds.

    We have successfully gotten many medical devices and cleared, and would be delighted to help with yours.

  • Regulatory Affairs - ROW

    The world can be complicated place when you wish to sell your medical devices. Figuring out a strategy to get the most market bang for your buck by choosing countries of introduction wisely is well worth your time.

    To the question of which countries to release in first, the answer is "it depends". It depends upon your product type and classification, your certification status, and other factors. Let's talk.

  • Audits - Gap & Internal

    If you are expecting to be audited by FDA or your notified body it makes sense to take a good look at your preparedness before the fact. Armed with a gap assessment you can begin the process of continual improvement and will also have in hand a strategy for answering audit findings. We've been in situations where a gap audit and subsequent actions have helped to avoid warning letters.

    Is your company keeping up with internal audits? They are easy to schedule, not so easy to consistently perform. Your people are busy, other things come up, etc. We can help you to set up a schedule and then be on site to perform these critical self-inspections. Our audit reports are to the point and understandable and will help you in assuring that violations are found and addressed in a timely manner.

    Of course we offer QSIT and MDSAP audits.

  • Audits - Supplier

    Your quality system calls for qualification audits for your critical suppliers. We are expert in supplier evaluation, having spent many years in manufacturing, R&D, and QA/RA.

    To date we have done supplier audits all across the US, in Germany, Czech Republic, Switzerland, Italy, China, Taiwan, and Singapore. The companies we have  inspected often thank us for our constructive suggestions in how to make improvements to their systems and processes.

  • Audits - Due Diligence / Pre-acquisition

    Are you thinking of acquiring another medical device company? You will almost certainly have your financial team look at the economics and stability of the target company.

    Unfortunately we have seen too many times where an impartial evaluation of the technological and regulatory maturity of the target company were inadequately evaluated. This has led to acquisitions that did not result in the desired product introductions within the time and dollar budgets anticpated or sometimes at all.

    Going to buy a 510(k)? Did you know that the clearance without the DHF is pretty much a compliance issue waiting to happen? We can help you evaluate whether you are buying a ready-to-market product or a headache.

  • eMDR

    FDA has mandated that MDR reports be provided electronically. Even if your company never needs to submit an MDR you will likely be cited on inspection if you don't have a functioning account with the FDA ESG gateway.

    Basically there are two choices when setting up this type of system:

    • Buy a commercial system for mass uploads
    • Use the FDA-supplied eSubmitter tool

    If you have many reports each month the commercial tool is the way to go. Or if you have a great IT and software development team you can write your own.

    If you have a modest number (or anticpate zero) submissions the second option is for you. In our experience  setting up an account with FDA and getting it to work can be challenging.

    NJK offers a third option - outsourced eMDR reporting. We can provide you with the necessary authorization letter to FDA to permit us to do reporting for you, then set up an account that we administer.

    We will even create an online page for you to help in providing us the information needed to report to FDA. Easy.

  • Electronic Training

    21 CFR 820.25(b) states:

    "Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented."

    It has been our experience that documenting training using a paper system is very difficult. While there are commercial solutions that issue training, track compliance, and offer optional competency quizzes these systems are both expensive and difficult to use and administer.

    NJK in collaboration with NXSRI has developed an electronic training system that does what you need at a cost you can afford. It is simple for trainees and logical for your training manager. Best of all, you can outsource the operation of the system to NJK should you desire. One less chore for your staff.

    Our electronic training system is 21CFR11 and GDPR compliant.

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